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Intracoronary Bolus Only Compared With Intravenous Bolus and 12-hours Infusion of Abciximab in Non-ST Elevation Myocardial Infarction.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Seoul National University Bundang Hospital
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01080638
First received: February 16, 2010
Last updated: March 2, 2010
Last verified: March 2010
History of Changes
  Purpose

Intracoronary bolus Abciximab single is non-inferior to intravenous and continuous 12- hours infusion in the size reduction of infarction on cardiac magnetic resonance in Non-ST elevation Myocardial infarction.


Condition Intervention Phase
Myocardial Infarction
Angioplasty
 Drug: glycoprotein IIb/IIIa inhibitor (abciximab)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Abciximab
U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • In cardiac MRI- infarct size (total late enhancement volume at day 3-7) [ Time Frame: day 3~7 after percutaneous coronary intervention ] [ Designated as safety issue: No ]
    MRI: magnetic resonance image


Secondary Outcome Measures:
  • in-hospital and after 1-months:the major adverse cardiovascular events : death, myocardial infarction, hospitalization for heart failure, myocardial ischemia, etc. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • b. major bleeding : Hemoglobin 4 or more reduction, 2-unit If you need more than two RBC transfusions, intracranial or retroperitoneal bleeding, urgent operation for bleeding complication. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    RBC: red blood cell

  • TIMI III flow count /myocardial blush score after PCI [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    TIMI: thrombolysis in myocardial infarction PCI: percutaneous coronary intervention

  • At cardiac MRI : LV ejection fraction,LV end-systolic volume,LV end diastolic volume,regional wall motion score index [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    LV: left ventricle

  • Discharge, 1- month after comparing NT-proBNP [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    NT-proBNP : N-terminal pro-B-Type natriuretic peptide


Estimated Enrollment: 150
Study Start Date: October 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abciximab IC bolus
After CAG, For patients with undergoing percutaneous coronary intervention, intracoronary only or intravenous bolus abciximab(0.25mg/kg body weight) administration with intravenous bolus group has subsequent 12-hours continuous infusion at a dose 0.125ug/kg per minute (maximum: 10ug/min)
 Drug: glycoprotein IIb/IIIa inhibitor (abciximab)
patients intracoronary bolus only group and intravenous bolus and 12-hours continuous infusion group bolus:0.25mg/kg body weight,continus 12hrs-0.125ug/kg per minute(maximum: 10ug/min)
Active Comparator: Abciximab IV bolus and 12hr continuous Drug: glycoprotein IIb/IIIa inhibitor (abciximab)
patients intracoronary bolus only group and intravenous bolus and 12-hours continuous infusion group bolus:0.25mg/kg body weight,continus 12hrs-0.125ug/kg per minute(maximum: 10ug/min)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • non-ST segment elevation acute myocardial infarction
  • within 48 hours presence of chest pain
  • Troponin-T or I positive before CAG
  • First myocardial infarction
  • will be performed coronary angioplasty

Exclusion Criteria:

  • under 18 years of age,80 years or older
  • Bleeding tendency
  • History of major surgery within 4 weeks
  • Major stroke within 2 years
  • Thrombocytopenia (<120,000 / uL)
  • Cardiogenic shock
  • Known allergy to aspirin, heparin, or abciximab
  • Contraindication of MRI at study entry (implanted pacemakers, defibrillators, intracranial metallic implants etc)
  • Chronic atrial fibrillation
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01080638

Contacts
Contact: Myung-Ki Seo, MD 82-2-2072-3757 clotinab@gmail.com
Contact: Hyun-Jae Kang, Prof 82-2-2072-2279 nowkang@snu.ac.kr

Locations
Korea, Republic of
Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Myung-Ki Seo, MD     82-2-2072-3757     clotinab@gmail.com    
Contact: Hyun-Jae Kang, Prof     82-2-2072-2279     nowkang@snu.ac.kr    
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Bundang Hospital
Investigators
Study Director: Hyun-Jae Kang, Prof Assistant professor, Cardiology, Department of internal medicine,Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Hyo-Soo Kim/ Prof, Director of Cardiac Catheterization Laboratory & Coronary Intervention of Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01080638     History of Changes
Other Study ID Numbers: H-0906-046-283
Study First Received: February 16, 2010
Last Updated: March 2, 2010
Health Authority: Republic of Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
abciximab
Myocardial Infarction
angioplasty
Platelet

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Krestin
Abciximab
Antibiotics, Antineoplastic
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Interferon Inducers
Radiation-Protective Agents
Protective Agents
Platelet Aggregation Inhibitors
Hematologic Agents
Anticoagulants

ClinicalTrials.gov processed this record on May 22, 2013